EvolvRehab - MoveWell Virtual Platform for Stroke Survivors Rapid Rehabilitation Through Fun Exergaming-based Learning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fugl Meyer Assessment
研究概览
简要总结
This study includes two stages to develop the use of EvolvRehab telerehabilitation in the use of Stroke patients, early after stroke. All tasks will be conducted by multiple research sites. Stage 2 will include at least 6 weeks of study intervention, and up to 6 months follow-up, where possible.
详细描述
All tasks in this phase will be conducted by at least two research sites (University of Exeter (site 1) and University of Bristol (site 2)) and the results from stage 1 of the study will be used to inform stage 2, following an amendment to incorporate any changes required.
Stage 1, phase 1: Review of product and processes for the preliminary pilot. The investigators will adopt a Person-Based Approach (user-Centred Design plus behavioural science) to further co-develop/refine the technology and clinical processes for use in National Health Service (NHS) stroke community services (n=15).
Stage 1, phase 2: Iterative pilot. EvolvRehab/MoveWell will be iteratively piloted in five stroke survivors' homes in one NHS team. The investigators will purposefully recruit a heterogeneous sample (e.g. gender, digital literacy, and home context). For this intervention stage of the pilot, patients will give consent. Participants will use EvolvRehab/MoveWell for one week. The research therapist will visit participants' homes alongside research staff to provide support and monitor home safety. A log of issues and feedback will be compiled. We will collect system data to finalise system refinements.
Stage 1, phase 3: Staff focus group. Rehab team staff (clinicians, carers, managers; n = 5) from Site 1 will be convened to agree how EvolvRehab will be deployed in community stroke services. The investigators will identify barriers and facilitators to deployment and report how these will be addressed. This will be advertised via poster which will be sent via email to stakeholders already involved in the study.
Stage 1, phase 4: Service user interviews. Semi-structured interviews will be held with stroke survivors used in stage 1, phase 2 (n=5) to explore issues experienced in using the system in their homes. The investigators will explore support structures (e.g., social networks) and barriers/ facilitators to engagement. Potential changes to software, hardware, support, and training will be mapped and reported. Patient/carer instruction materials will be created. The investigators will create a Digital Inclusion Package. Patients will be contacted to organise this via telephone and/or email.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing motor difficulties in using the paretic arm, with some use of hand/arm as determined by clinical treatment team
- •Able to safely participate and complete EvolvRehab activities as determined by clinical treatment team
- •Male/female ≥18 years old
- •Recently had a stroke requiring upper limb intensive rehabilitation
- •The participant is expected to be able to use equipment for a minimum of 1 week
- •Capacity to consent to participate
- •Able to communicate adequately in English with the research team
排除标准
- •Participating in another intervention which the research team deem could interfere with study outcomes
- •Any medical condition compromising the safety or the ability to take part to the study as determined by the clinical treatment team (such as insufficient vision or hearing, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
- •History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
- •Cognitive or communication impairment such that the participant is unable to follow a two stage command
- •Moderate to severe hemi-spatial neglect compromising the ability to take part to the study, as determined by research team
结局指标
主要结局
Fugl Meyer Assessment
时间窗: 6 weeks
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Movements are scored between 0 (none), 1 (partial) or 2 (full/ can be elicited) for reflex activity, volitional movement within synergies, volitional movement mixing synergies, volitional movement with little or no synergy, for upper body including wrist and hand. Normal reflex activity is scored 0 (hyper), 1 (lively) or 2 (normal). Co-ordination is scored 0 (marked), 1 (slight) or 2 (none). Sensation is scored 0 (anesthesia), 1 (hypoesthesia or dysesthesia), 2 (normal) Joint motion is scored 0 (only few degrees), 1 (decreased), 2 (normal) Joint pain is scored 0 (pronounced pain), 1 (some pain), 2 (no pain)
次要结局
- Free-living activity(6 weeks)
- Range of motion(6 weeks)
- System Usability Scale(6 weeks)
- Carer Strain Index (CSI)(6 weeks)
- European Quality of Life questionnaire (Eq-5D-5L)(6 weeks)
- The World Health Organization Disability Assessment Schedule (WHODAS)(6 weeks)
- Acceptability(6 weeks)
- Shoulder Abduction Finger extension(6 weeks)
- Grip strength(6 weeks)
- Health resource use questionnaire(6 weeks)
- Incidence of adverse events(6 weeks)
- Process interviews(6 weeks)
- Movement quantity in "movewell" activities on the EvolvRehab system(6 weeks)
- Movement quality in "movewell" activities on the EvolvRehab system(6 weeks)